Indication
Tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1) or Patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2 lesion load as compared to a previous recent MRI.
In other countries
The same active substances on other registers, the same brand first.
National listings
The national registers that list this EU medicine.
- TyrukoCanada · 300 MG / 15 ML · Solution · Polpharma Biologics S.A.Same brand
- Tyruko 300 MG Concentrado Para Solucion Para PerfusionSpain · 300 mg · concentrado para solución para perfusión · Sandoz GmbhSame brand
- TyrukoCroatiaSame brand
- TyrukoItaly · Concentrato per soluzione per infusione · Sandoz GMBHSame brand
- Tyruko 300 mg concentraat voor oplossing voor infusieNetherlands · Concentraat voor oplossing voor infusie · Sandoz GmbHSame brand
- TyrukoUnited States · 300MG/15ML · injectable · Sandoz INCSame brand
- TysabriBrazil · Biogen Brasil Produtos Farmaceuticos LtdaSame form
- TysabriCroatiaSame form
- TYSABRI 300mgRomania · 20mg/ml · conc. pt. sol. perf. · Biogen Netherlands B.V.Same form
- TYSABRI 300mgRomania · 20mg/ml · conc. pt. sol. perf. · Biogen Idec LTD Innovation HouseSame form
- TysabriSaudi Arabia · Vetter Pharma-Fertigung, GMBH & Co. KGSame form
- Tysabri 300 MG/15MLSaudi Arabia · Vetter Pharma-Fertigung, GMBH & Co. KGSame form
- Tysabri 300 MG/15MLSaudi Arabia · Biogen Idec Denmark Manufacturing APSSame form
- TysabriCanada · 300 MG / 15 ML · Solution · Biogen Canada INCSame substance
- Tysabri 150 MG Solucion Inyectable en Jeringa PrecargadaSpain · 150 mg/ml · solución inyectable en jeringa precargada · Biogen Netherlands B.V.Same substance
- TYSABRI 300 mg CONCENTRADO PARA SOLUCION PARA PERFUSIONSpain · 20 mg · concentrado para solución para perfusión · Biogen Netherlands B.V.Same substance
- TysabriItaly · Soluzione iniettabile in siringa pre-riempita · Biogen Netherlands BVSame substance
- Tysabri 150 mg oplossing voor injectie in een voorgevulde spuitNetherlands · Oplossing voor injectie · Biogen Netherlands B.V.Same substance
- Tysabri 300 mg (20 mg/ml) concentraat voor oplossing voor injectie, concentraat voor oplossing voor injectieNetherlands · Concentraat voor oplossing voor infusie · Biogen Netherlands B.V.Same substance
- TysabriNew Zealand · Inj 20 mg per ml, 15 ml vialSame substance
- TysabriSerbia · 300mg/15mL · koncentrat za rastvor za infuziju · Medis Pharma D.O.O. BeogradSame substance
- TysabriSerbia · 300mg/15mL · koncentrat za rastvor za infuziju · Medis Pharma D.O.O. BeogradSame substance
- Tysabri®Serbia · 150mg/mL · rastvor za injekciju u napunjenom injekcionom špricu · Medis Pharma D.O.O. BeogradSame substance
- Tysabri Concentrate for Solution for Infusion 300mg/15mlSingapore · 300 mg/15mL · infusion, solution concentrate · Eisai (Singapore) Pte. LTD.Same substance
- TysabriUnited States · 300MG · vial · Biogen IdecSame substance
Documents
The official texts, at the regulator.
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
Source: European Medicines Agency, EPAR list (imported 10 June 2026).
Licence: EMA content, reuse with acknowledgement · Added 10 Jun 2026
Report an error or request removalCorrections from the holder or the register are welcome.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Active substance
- Natalizumab
- Register
- European Union (EMA)
- Status
- Authorised
- Authorised
- 22 Sept 2023
- Registration
- EMEA/H/C/005752
- Marketing authorisation holder
- Sandoz GmbH
- ATC code
- L04AG03
- Therapeutic area
- Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis
- Procedure
- EU centralised
- EMA product number
- EMEA/H/C/005752